Bentson G01063Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002010635), received between Jul 21, 2017 and Nov 6, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Unraveled Material; Unraveled Material

  IT WAS ORIGINALLY REPORTED THAT DURING A LOWER EXTREMITY ANGIOGRAPHY PROCEDURE VIA ACCESS THROUGH THE FEMORAL ARTERY WITH A TARGET OF THE SUPERFICIAL FEMORAL ARTERY (FSA), A BENTSON STRAIGHT FIXED CORE WIRE GUIDE BEGAN TO "SWELL" AND GOT STUCK INSIDE ANOTHER MANUFACTURER'S CATHETER. THE CATHETER WAS CUT TO REMOVE THE WIRE GUIDE FROM THE PATIENT. THE PHYSICIAN HAD TO PULL "PRETTY HARD" TO PULL THE WIRE GUIDE OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S WIRE GUIDE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE LEFT INSIDE THE PATIENT. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 21OCT2025, THE COIL OF THE WIRE GUIDE WAS FOUND TO BE UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485846 ↗
• MalfunctionApr 23, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING TREATMENT OF PERIPHERAL ARTERY DISEASE, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNRAVELED AT THE TIP. THE WIRE WAS COMPLETELY REMOVED FROM THE PATIENT, WHO WAS REPORTEDLY NOT AFFECTED AND DOING WELL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894079 ↗
• MalfunctionNov 20, 2024Unraveled Material; Unraveled Material

  AS REPORTED, PRIOR TO PATIENT CONTACT FOR AN UNKNOWN PROCEDURE, TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES "SHEARED". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733802 ↗
• MalfunctionAug 25, 2023Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED 30OCT2023. HEPARINIZED SALINE WAS USED TO ACTIVATE THE COATING. A DIFFERENT, UNSPECIFIED WIRE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624141 ↗
• MalfunctionMay 19, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED, DURING AN ENDOVASCULAR REPAIR VIA GROIN ACCESS, A SHARP WIRE WAS NOTED TO BE PROTRUDING FROM A BENTSON STRAIGHT FIXED CORE WIRE GUIDE. THIS WAS NOTED WHEN THE DEVICE WAS IN THE PATIENT. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE WIRE. THE WIRE WAS REMOVED AND ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435985 ↗
• MalfunctionMar 3, 2022Unraveled Material; Unraveled Material

  AS REPORTED, WHILE OBTAINING ACCESS WITH A BENTSON STRAIGHT FIXED CORE WIRE GUIDE, THE DEVICE UNRAVELED AND ELONGATED 7 TO 8CM PAST THE TIP. THE DEVICE WAS RETRIEVED WITHOUT ISSUE, AND THE AORTIC GRAFT PLACEMENT PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT REFERENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659675 ↗
• MalfunctionApr 28, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11738693 ↗
• MalfunctionMar 1, 2021Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393321 ↗
• MalfunctionMay 29, 2020Stretched; Stretched

  AS REPORTED, DURING A PLUG-ASSISTED RETROGRADE TRANSVENOUS OBLITERATION OF GASTRIC VERICES, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE BECAME STUCK IN ANOTHER MANUFACTURER'S BALLOON CATHETER. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL VEIN, AND THE DEVICE PASSED THROUGH AN UNKNOWN 5 FRENCH CATHETER. THE CATHETER WAS REMOVED AND ANOTHER MANUFACTURER'S BALLOON WAS ADVANCED OVER THE WIRE. THE USER THEN ATTEMPTED TO ADVANCE THE WIRE FOR MORE "PURCHASE"; HOWEVER, THE WIRE WOULD NOT ADVANCE. THE WIRE AND BALLOON CATHETER WERE THEN BOTH REMOVED FROM THE PATIENT. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER WIRE TO COMPLETE THE PROCEDURE. THE ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE. ON RETURN OF THE DEVICE ON 30APR2020, THE DEVICE WAS NOTED TO BE ELONGATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101460 ↗
• MalfunctionMay 1, 2020Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016905 ↗
• MalfunctionMar 13, 2018Difficult to Remove; Delamination; Difficult to Remove; Delamination

  IT WAS REPORTED THAT DURING A FISTULOGRAM, THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS UNABLE TO BE REMOVED FROM ANOTHER MANUFACTURER'S BALLOON CATHETER UNTIL IT WAS OUTSIDE OF THE PATIENT'S ANATOMY. THE WIRE GUIDE WAS REMOVED BY REMOVING THE BALLOON THAT THE WIRE WAS PLACED THROUGH. THE GREEN COATING OF THE WIRE GUIDE WAS OBSERVED TO BE DETACHED FROM THE WIRE. ANOTHER DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO KINKING WAS NOTED PRIOR TO USE OF THE WIRE GUIDE; RESISTANCE WAS ENCOUNTERED DURING REMOVAL. THE WIRE GUIDE COATING WAS ACTIVATED PRIOR TO USE BY DIPPING THE WIRE IN HEPARINIZED SALINE. THE WIRE WAS PLACED IN A BASIN WITH HEPARINIZED SALINE WHILE NOT IN USE THROUGHOUT THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.  ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7334233 ↗
• MalfunctionFeb 23, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A RIGHT LOWER EXTREMITY ANGIOGRAM, THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNRAVELED. THE WIRE GUIDE WAS ABLE TO BE PULLED OUT OF THE PATIENT, AND ANOTHER WIRE GUIDE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7292418 ↗
• MalfunctionSep 11, 2017Material Frayed; Material Frayed

  IT WAS REPORTED, UPON OPENING THE PACKAGING OF TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES, THE WIRE WAS OBSERVED TO BE FRAYED APPROXIMATELY 5 INCHES FROM THE TIP. MALFUNCTION OBSERVED PRIOR TO USE. NO ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6855828 ↗
• MalfunctionJul 21, 2017Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING THE LEG ANGIOGRAM PROCEDURE, THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE BECAME STUCK AND LODGED ON THE .035 BALLOON CATHETER. WHILE STRUGGLING TO REMOVE THE WIRE THROUGH THE BALLOON CATHETER AND SHEATH, THE MANDRIL UNRAVELED WHEN IT MET WITH RESISTANCE. THE WIRE WAS ABLE TO BE REMOVED FROM PATIENT WITHOUT ISSUE. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6734245 ↗